510(k) K062966
- Device
- QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS
- Applicant
- SERADYN INC.
- 510(k) number
- K062966
- Product code
- ORH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-01-12
- Date received
- 2006-09-29
- Regulation
- 862.3350
- Classification name
- Lamotrigine Assay
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JACK ROGERS
- Address
- 7998 Georgetown Rd. Suite 1000 Indianapolis IN US 46268 46268
FDA Registration Numbers#
- 3010939897
- 3005755244
Source Documents#
Other 510(k) Records For Product Code ORH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K101305 | ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL | Ark Diagnostics, Inc. | 2010-10-29 |
Legacy Summary#
summary
FDA Review#
Decision Summary